Category Archives: Healthcare

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Not So Fast – FDA Retracts Authorization for Some Respirators Made in China

Immunity under the Public Readiness and Emergency Preparedness (“PREP”) Act is a moving target for government contractors and other companies manufacturing or distributing personal protective equipment (PPE) in the COVID-19 public health response. We wrote previously about new liability protections afforded to manufacturers and distributors of certain face masks approved by National Institute for Occupational … Continue Reading

PREP Act Update: All NIOSH-Approved Respirators Now Are Covered Countermeasures Eligible for Immunity

All respirators approved by the National Institute of Occupational Safety and Health (“NIOSH”) now are “covered countermeasures” under the Public Readiness and Emergency Preparedness (“PREP”) Act provisions of the Public Health Service Act, and their manufacturers and distributors are eligible for immunity from suits for injury and death resulting from use of the masks in … Continue Reading

COVID-19 Changes Contracting at the VA

The novel coronavirus (“COVID-19”) pandemic has given Department of Veterans Affairs (“VA”) contractors several powerful new tools in their toolbelts, and VA contractors should not leave available protections on the table. VA contractors, including those supplying medical devices under the MSPV-NG bridge contract and pharmaceuticals on a VA Federal Supply Schedule (“FSS”), now can negotiate … Continue Reading

FCPA Landmines Beneath the Surface of the COVID-19 Crisis

COVID-19 took the world by surprise and continues to spread across the globe in more than 210 countries and counting.  The outbreak in the United States escalated rapidly, with over 585,000 confirmed cases as of April 14, 2020.  The federal government and a number of hard-hit states were caught off guard, and soon learned that … Continue Reading

Seize The Day (and the PPE) – An Overview of State and Local Rules Governing the Possession and/or Sale of Personal Protective Equipment (“PPE”) during the COVID-19 Public Health Emergency

As the Federal Government struggles to secure a sufficient volume of Personal Protective Equipment (“PPE”) – i.e., gloves, masks, gowns, face shields, etc. – for the nation’s health care workers and first responders, states and localities have begun taking it upon themselves to identify and protect the resources available within their geographic boundaries. These efforts … Continue Reading

The CARES Act – Who’s Minding the Store?

There is more than $2 trillion on the line and the multi-trillion-dollar question is: Who’s minding the store?  On March 27, 2020, in response to the financial set-back created by the novel COVID-19 pandemic, President Trump signed into law the more than $2 trillion Coronavirus Aid, Relief, and Economic Security Act (the “CARES Act”) – … Continue Reading

Gifting Goods & Services to the U.S. Government in the Wake of the Coronavirus Outbreak

COVID-19 (a.k.a. the Coronavirus) is upon us and it looks like it is here to stay, at least for the foreseeable future.  In January, the Department of Health and Human Services declared the Coronavirus outbreak to constitute a Public Health Emergency, and on March 13, 2020, President Trump declared it a National Emergency.  The President … Continue Reading

Families First Coronavirus Response Act: Face Mask Manufacturers and Distributors Protected from Liability for Coronavirus Deaths

On March 18, 2020, the President signed into law the Families First Coronavirus Response Act, H.R. 6201, Pub. L. No. 116-127 (the “Coronavirus Response Act”). Among other measures in response to the current pandemic, this legislation offers manufacturers and distributors of industrial-grade face masks, referred to as “personal respiratory protective devices,” immunity from liability arising … Continue Reading

COVID-19 Federal Contractor’s Survival Guide 2.0

Last week, we (Ryan and Jonathan) published the COVID-19 Federal Contractor’s Survival Guide in the Coalition For Government Procurement’s Friday Flash. The Guide was very well received – perhaps because it didn’t once instruct anyone to wash his/her hands – and several readers asked us to expand it to cover additional topics and new developments. … Continue Reading

Key Provisions in the Senate Stimulus Bill

On March 25, 2020 the Senate passed a $2 trillion stimulus bill “[p]roviding emergency assistance and healthcare response for individuals, families and businesses affected by the 2020 coronavirus pandemic.”  The House and the President are both expected to approve the Bill in short order.  The Bill contains many provisions important to all companies, including government … Continue Reading

Presidential Executive Order Calls on HHS to Issue Priority Contracts and Allocate Scarce Medical Resources

On March 18, 2020, the President issued an Executive Order on Prioritizing and Allocating Health and Medical Resources to Respond to the Spread of COVID-19 (the “EO”). The EO was issued pursuant to the Defense Production Act of 1950 (50 U.S.C. §4501 et seq.) (“DPA”), which allows the President to invoke special Federal Contracting powers … Continue Reading

What Does it Mean to Manufacture? Federal Circuit’s Acetris Decision Fundamentally Alters Trade Agreements Act Compliance

On February 10, 2020, the U.S. Court of Appeals for the Federal Circuit issued its long-awaited decision in Acetris Health LLC v. United States, No. 2018-2399 (Feb. 10, 2020). In Acetris, the Federal Circuit was asked to interpret the country of origin requirements under the Trade Agreements Act of 1979 (“TAA”) and related regulations. For … Continue Reading

Federal Circuit Changes the Game for Selling Single-API Drugs to the Government

Selling drugs to the Government just got a lot simpler.  In Acetris Health LLC v. United States, No. 2018-2399 (Feb. 10, 2020), the Federal Circuit opened the Government door to all drugs “manufactured”—that is, measured, weighed, mixed, and compounded—in the United States, regardless of where the active pharmaceutical ingredient (“API”) originates.  This is a vast … Continue Reading

Why the Health Care Industry Should Be Concerned About Section 889 of the 2019 National Defense Authorization Act

On August 13, 2018, President Trump signed into law the National Defense Authorization Act (NDAA) of 2019. While the annual NDAAs are tracked, analyzed, and picked apart with great care by the federal contracting community, the health care industry typically pays them little mind. But ignoring the 2019 NDAA would be a big mistake, because … Continue Reading

What’s the VA Got to Do With It? Military Medical Procurement Changes Reach the VA

There are big changes happening in military healthcare procurement. Some are unsurprising given the October 1, 2019 deadline for the reorganization of all military hospitals and clinics under the management of the Department of Defense (DOD), Defense Health Agency (DHA). But some may be unexpected, reaching all the way to Department of Veterans Affairs (VA) … Continue Reading

VA Begins Seeking MSPV 2.0 Partners

The Department of Veterans Affairs (“VA”), Veterans Health Administration (“VHA”) has begun the move toward its new Medical/Surgical Prime Vendor (“MSPV”) 2.0 program by issuing the formal RFP seeking prime vendors for distribution and supply management services on June 3, 2019. The MSPV 2.0 program will replace the current MSPV-Next Generation program, and is designed … Continue Reading

Veterans Are First at the VA Following New Class Deviation Implementing Recent Federal Circuit Mandate

In its most recent attempt to strike the appropriate balance between the Veterans First and AbilityOne programs, the U.S. Department of Veterans Affairs (“VA”) issued on May 20, 2019 a class deviation to the VA Acquisition Regulations (“VAAR,” 48 C.F.R. Chapter 8), instructing contracting officers to conduct a “Rule of Two” analysis before procuring from … Continue Reading

How to Prevent or Defend Against Business Crimes, including Trade Secrets and Human Trafficking

The C-Suite rarely wants to consider, much less worry about, the impacts of criminal conduct on their business. The reality is, however, companies can and do get pulled into criminal and quasi-criminal enforcement actions as both victims and (albeit unintentional) perpetrators. Two areas of criminal conduct that perhaps do not receive the amount of C-Suite … Continue Reading

TRICARE: Defense Health Agency Issues Request for Information Regarding Formulary Management – Submission Deadline: February 5, 2019

The Defense Health Agency (DHA), which manages the TRICARE health care benefits, has issued a Request for Information (RFI) regarding inpatient-clinic administered pharmaceuticals formulary management. In other words, responding vendors have the opportunity to shape the standard list of drugs prescribed across all military medical treatment facilities (MTFs), as well as the broader program administering … Continue Reading
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